Long term oxygen therapy system

ABSTRACT

A long term oxygen therapy system having an oxygen supply directly linked with a patient&#39;s lung or lungs may be utilized to more efficiently treat hypoxia caused by chronic obstructive pulmonary disease such as emphysema and chronic bronchitis. The system includes an oxygen source, one or more valves and fluid carrying conduits. The fluid carrying conduits link the oxygen source to diseased sites within the patient&#39;s lungs.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application Ser.No. 60/399,907 filed on Jul. 31, 2002.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to systems for delivering oxygen, and moreparticularly, to systems for delivering oxygen directly to diseasedportions of the lungs.

2. Discussion of the Related Art

As a result of studies that date back to the 1930's and particularlystudies conducted in the 1960's and early 1970's, it has been determinedthat long-term continuous oxygen therapy is beneficial in the treatmentof hypoxemic patients with chronic obstructive pulmonary disease. Inother words, a patient's life and quality of life can be improved byproviding a constant supplemental supply of oxygen to the patient'slungs.

However, with the desire to contain medical costs, there is a growingconcern that the additional cost of providing continuous oxygen therapyfor chronic lung disease will create an excessive increase in the annualcost of oxygen therapy. Thus, it is desirable that oxygen therapy, whenprovided, be as cost effective as possible.

The standard treatment for patients requiring supplemental oxygen isstill to deliver oxygen from an oxygen source by means of a nasalcannula. Such treatment, however, requires a large amount of oxygen,which is wasteful and can cause soreness and irritation to the nose, aswell as being potentially aggravating. Other undesirable effects havealso been reported. Various other medical approaches which have beenproposed to help reduce the cost of continuous oxygen therapy have beenstudied.

Various devices and methods have been devised for performing emergencycricothyroidotomies and for providing a tracheotomy tube so that apatient whose airway is otherwise blocked may continue to breath. Suchdevices are generally intended only for use with a patient who is notbreathing spontaneously and are not suitable for the long term treatmentof chronic lung disease. Typically, such devices are installed bypuncturing the skin to create a hole into the cricoid membrane of thelarynx above the trachea into which a relatively large curvedtracheotomy tube is inserted. As previously described, the use of suchtubes has been restricted medically to emergency situations where thepatient would otherwise suffocate due to the blockage of the airway.Such emergency tracheotomy tubes are not suitable for long term therapyafter the airway blockage is removed.

Other devices which have been found satisfactory for emergency orventilator use are described in U.S. Pat. No. 953,922 to Rogers; U.S.Pat. No. 2,873,742 to Shelden; U.S. Pat. No. 3,384,087 to Brummelkamp;U.S. Pat. No. 3,511,243 to Toy; U.S. Pat. No. 3,556,103 to Calhoun; U.S.Pat. No. 2,991,787 to Shelden, et al; U.S. Pat. No. 3,688,773 to Weiss;U.S. Pat. No. 3,817,250 to Weiss, et al.; and U.S. Pat. No. 3,916,903 toPozzi.

Although tracheotomy tubes are satisfactory for their intended purpose,they are not intended for chronic usage by outpatients as a means fordelivering supplemental oxygen to spontaneously breathing patients withchronic obstructive pulmonary disease. Such tracheotomy tubes aregenerally designed so as to provide the total air supply to the patientfor a relatively short period of time. The tracheotomy tubes aregenerally of rigid or semi-rigid construction and of caliber rangingfrom 2.5 mm outside diameter in infants to 15 mm outside diameter inadults. They are normally inserted in an operating room as a surgicalprocedure or during emergency situations, through the crico-thyroidmembrane where the tissue is less vascular and the possibility ofbleeding is reduced. These devices are intended to permit passage of airin both directions until normal breathing has been restored by othermeans.

Another type of tracheotomy tube is disclosed in Jacobs, U.S. Pat. Nos.3,682,166 and 3,788,326. The catheter described therein is placed over14 or 16 gauge needle and inserted through the crico-thyroid membranefor supplying air or oxygen and vacuum on an emergency basis to restorethe breathing of a non-breathing patient. The air or oxygen is suppliedat 30 to 100 psi for inflation and deflation of the patient's lungs. TheJacobs catheter, like the other tracheotomy tubes previously used, isnot suitable for long term outpatient use, and could not easily beadapted to such use.

Due to the limited functionality of tracheotomy tubes, transtrachealcatheters have been proposed and used for long term supplemental oxygentherapy. For example the small diameter transtracheal catheter (16gauge) developed by Dr. Henry J. Heimlich (described in THE ANNALS OFOTOLOGY, RHINOLOGY & LARYNGOLOGY, November-December 1982; RespiratoryRehabilitation with Transtracheal Oxygen System) has been used by theinsertion of a relatively large cutting needle (14 gauge) into thetrachea at the mid-point between the cricothyroid membrane and thesternal notch. This catheter size can supply oxygen up to about 3 litersper minute at low pressures, such as 2 psi which may be insufficient forpatients who require higher flow rates. It does not, however, lenditself to outpatient use and maintenance, such as periodic removal andcleaning, primarily because the connector between the catheter and theoxygen supply hose is adjacent and against the anterior portion of thetrachea and cannot be easily seen and manipulated by the patient.Furthermore, the catheter is not provided with positive means to protectagainst kinking or collapsing which would prevent its effective use onan outpatient basis. Such a feature is not only desirable but necessaryfor long term outpatient and home care use. Also, because of itsstructure, i.e. only one exit opening, the oxygen from the catheter isdirected straight down the trachea toward the bifurcation between thebronchi. Because of the normal anatomy of the bronchi wherein the leftbronchus is at a more acute angle to the trachea than the rightbronchus, more of the oxygen from that catheter tends to be directedinto the right bronchus rather than being directed or mixed for moreequal utilization by both bronchi. Also, as structured, the oxygen canstrike the carina, resulting in an undesirable tickling sensation andcough. In addition, in such devices, if a substantial portion of theoxygen is directed against the back wall of the trachea causing erosionof the mucosa in this area which may cause chapping and bleeding.Overall, because of the limited output from the device, it may notoperate to supply sufficient supplemental oxygen when the patient isexercising or otherwise quite active or has severe disease.

Thus none of the above-described prior art devices are fully suitablefor outpatient use on a long term basis.

SUMMARY OF THE INVENTION

The present invention overcomes the disadvantages associated with thelong term oxygen therapy systems as briefly described above.

In accordance with one aspect, the present invention is directed to along term oxygen therapy system. The long term oxygen therapy systemcomprises an oxygen supply, at least one conduit having a first endconnected to the oxygen supply and a second end passing through thethoracic wall and lung of a patient thereby establishing fluidcommunication between the oxygen supply and the inner volume of thelung, and a sealing device connected to the at least one conduit, thesealing device providing a fluid tight seal between the at least oneconduit and the thoracic wall.

In accordance with another aspect, the present invention is directed toa long term oxygen therapy system. The long term oxygen therapy systemcomprises an oxygen supply, a valve, a first conduit having a first endconnected to the oxygen supply and a second end connected to the valve,at least one second conduit having a first end connected to the valveand a second end having multiple branches, one of the branches passingthrough the thoracic wall and lung of a patient thereby establishingfluid communication between the oxygen supply and the inner volume ofthe lung, and another of the branches passing through a bronchus of apatient thereby establishing fluid communication between the oxygensupply, the inner volume of the lung and the bronchus, and sealingdevices connected to the multiple branches, the sealing devicesproviding a fluid tight seal between the one of the branches passingthrough the thoracic wall and lung of the patient and the thoracic walland a fluid tight seal between the other of the branches passing througha bronchus of the patient and the thoracic wall of the patient.

In accordance with another aspect, the present invention is directed toa method for treating hypoxemic patients having chronic obstructivepulmonary disease. The method comprises creating an anastomotic openingextending from the thoracic wall and into the inner volume of a lung,supplying oxygen from a source directly into alveolar tissue of a lungthrough a conduit extending from the oxygen source and into the lungthrough the anastomotic opening, and establishing a fluid tight sealbetween the anastomotic opening and the conduit.

In accordance with another aspect, the present invention is directed toa method for treating hypoxemic patients having chronic obstructivepulmonary disease. The method comprises creating an anastomotic openingextending from the thoracic wall and into the inner volume of a lung,supplying oxygen from a source directly into alveolar tissue of a lungthrough a conduit extending from the oxygen source and into the lungthrough the anastomotic opening, establishing a fluid tight seal betweenthe anastomotic opening and the conduit, and venting air from the lunginto the bronchus through a second conduit.

The long term oxygen therapy system of the present invention deliversoxygen directly to diseased sites in a patient's lungs. Long term oxygentherapy is widely accepted as the standard treatment for hypoxia causedby chronic obstructive pulmonary disease, for example, pulmonaryemphysema. Pulmonary emphysema is a chronic obstructive pulmonarydisease wherein the alveoli of the lungs lose their elasticity and thewalls between adjacent alveoli are destroyed. As more and more alveoliwalls are lost, the air exchange surface area of the lungs is reduceduntil air exchange becomes seriously impaired. The combination of mucushypersecretion and dynamic air compression is a mechanism of airflowlimitation in chronic obstructive pulmonary disease. Dynamic aircompression results from the loss of tethering forces exerted on theairway due to the reduction in lung tissue elasticity. Essentially,stale air accumulates in the lungs, thereby depriving the individual ofoxygen. Various methods may be utilized to determine the location orlocations of the diseased tissue, for example, computerized axialtomography or CAT scans, magnetic resonance imaging or MRI, positronemission tomograph or PET, and/or standard X-ray imaging. Once thelocation or locations of the diseased tissue are located, anastomoticopenings are made in the thoracic cavity and lung or lungs and one ormore oxygen carrying conduits are positioned and sealed therein. The oneor more oxygen carrying conduits are connected to an oxygen source whichsupplies oxygen under elevated pressure directly to the diseased portionor portions of the lung or lungs. The pressurized oxygen essentiallydisplaces the accumulated air and is thus more easily absorbed by thealveoli tissue. In addition, the long term oxygen therapy system may beconfigured in such a way as to provide collateral ventilation bypass inaddition to direct oxygen therapy. In this configuration, an additionalconduit may be connected between the main conduit and the individual'strachea with the appropriate valve arrangement. In this configuration,stale air may be removed through the trachea when the individual exhalessince the trachea is directly linked with the diseased site or sites inthe lung via the conduits.

The long term oxygen therapy system of the present invention improvesoxygen transfer efficiency in the lungs thereby reducing oxygen supplyrequirements, which in turn reduces the patient's medical costs. Thesystem also allows for improved self-image, improved mobility, greaterexercise capability and is easily maintained.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following, more particular description of preferredembodiments of the invention, as illustrated in the accompanyingdrawings.

FIG. 1 is a diagrammatic representation of a first exemplary embodimentof the long term oxygen therapy system in accordance with the presentinvention.

FIG. 2 is a diagrammatic representation of a first exemplary embodimentof a sealing device utilized in conjunction with the long term oxygentherapy system of the present invention.

FIG. 3 is a diagrammatic representation of a second exemplary embodimentof a sealing device utilized in conjunction with the long term oxygentherapy system of the present invention.

FIG. 4 is a diagrammatic representation of a third exemplary embodimentof a sealing device utilized in conjunction with the long term oxygentherapy system of the present invention.

FIG. 5 is a diagrammatic representation of a fourth exemplary embodimentof a sealing device utilized in conjunction with the long term oxygentherapy system of the present invention.

FIG. 6 is a diagrammatic representation of a second exemplary embodimentof the long term oxygen therapy system in accordance with the presentinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Air typically enters the mammalian body through the nostrils and flowsinto the nasal cavities. As the air passes through the nostrils andnasal cavities, it is filtered, moistened and raised or lowered toapproximately body temperature. The back of the nasal cavities iscontinuous with the pharynx (throat region); therefore, air may reachthe pharynx from the nasal cavities or from the mouth. Accordingly, ifequipped, the mammal may breath through its nose or mouth. Generally airfrom the mouth is not as filtered or temperature regulated as air fromthe nostrils. The air in the pharynx flows from an opening in the floorof the pharynx and into the larynx (voice box). The epiglottisautomatically closes off the larynx during swallowing so that solidsand/or liquids enter the esophagus rather than the lower air passagewaysor airways. From the larynx, the air passes into the trachea, whichdivides into two branches, referred to as the bronchi. The bronchi areconnected to the lungs.

The lungs are large, paired, spongy, elastic organs, which arepositioned in the thoracic cavity. The lungs are in contact with thewalls of the thoracic cavity. In humans, the right lung comprises threelobes and the left lung comprises two lobes. Lungs are paired in allmammals, but the number of lobes or sections of lungs varies from mammalto mammal. Healthy lungs, as discussed below, have a tremendous surfacearea for gas/air exchange. Both the left and right lung is covered witha pleural membrane. Essentially, the pleural membrane around each lungforms a continuous sac that encloses the lung. A pleural membrane alsoforms a lining for the thoracic cavity. The space between the pleuralmembrane forming the lining of the thoracic cavity and the pleuralmembranes enclosing the lungs is referred to as the pleural cavity. Thepleural cavity comprises a film of fluid that serves as a lubricantbetween the lungs and the chest wall.

In the lungs, the bronchi branch into a multiplicity of smaller vesselsreferred to as bronchioles. Typically, there are more than one millionbronchioles in each lung. Each bronchiole ends in a cluster of extremelysmall air sacs referred to as alveoli. An extremely thin, single layerof epithelial cells lining each alveolus wall and an extremely thin,single layer of epithelial cells lining the capillary walls separate theair/gas in the alveolus from the blood. Oxygen molecules in higherconcentration pass by simple diffusion through the two thin layers fromthe alveoli into the blood in the pulmonary capillaries. Simultaneously,carbon dioxide molecules in higher concentration pass by simplediffusion through the two thin layers from the blood in the pulmonarycapillaries into the alveoli.

Breathing is a mechanical process involving inspiration and expiration.The thoracic cavity is normally a closed system and air cannot enter orleave the lungs except through the trachea. If the chest wall is somehowcompromised and air/gas enters the pleural cavity, the lungs willtypically collapse. When the volume of the thoracic cavity is increasedby the contraction of the diaphragm, the volume of the lungs is alsoincreased. As the volume of the lungs increase, the pressure of the airin the lungs falls slightly below the pressure of the air external tothe body (ambient air pressure). Accordingly, as a result of this slightpressure differential, external or ambient air flows through therespiratory passageways described above and fills the lungs until thepressure equalizes. This process is inspiration. When the diaphragm isrelaxed, the volume of the thoracic cavity decreases, which in turndecreases the volume of the lungs. As the volume of the lungs decrease,the pressure of the air in the lungs rises slightly above the pressureof the air external to the body. Accordingly, as a result of this slightpressure differential, the air in the alveoli is expelled through therespiratory passageways until the pressure equalizes. This process isexpiration.

Continued insult to the respiratory system may result in variousdiseases, for example, chronic obstructive pulmonary disease. Chronicobstructive pulmonary disease is a persistent obstruction of the airwayscaused by chronic bronchitis and pulmonary emphysema. In the UnitedStates alone, approximately fourteen million people suffer from someform of chronic obstructive pulmonary disease and it is in the top tenleading causes of death.

Chronic bronchitis and acute bronchitis share certain similarcharacteristics; however, they are distinct diseases. Both chronic andacute bronchitis involve inflammation and constriction of the bronchialtubes and the bronchioles; however, acute bronchitis is generallyassociated with a viral and/or bacterial infection and its duration istypically much shorter than chronic bronchitis. In chronic bronchitis,the bronchial tubes secrete too much mucus as part of the body'sdefensive mechanisms to inhaled foreign substances. Mucus membranescomprising ciliated cells (hair like structures) line the trachea andbronchi. The ciliated cells or cilia continuously push or sweep themucus secreted from the mucus membranes in a direction away from thelungs and into the pharynx, where it is periodically swallowed. Thissweeping action of the cilia functions to keep foreign matter fromreaching the lungs. Foreign matter that is not filtered by the nose andlarynx, as described above, becomes trapped in the mucus and ispropelled by the cilia into the pharynx. When too much mucus issecreted, the ciliated cells may become damaged, leading to a decreasein the efficiency of the cilia to sweep the bronchial tubes and tracheaof the mucus containing the foreign matter. This in turn causes thebronchioles to become constricted and inflamed and the individualbecomes short of breath. In addition, the individual will develop achronic cough as a means of attempting to clear the airways of excessmucus.

Individuals who suffer from chronic bronchitis may develop pulmonaryemphysema. Pulmonary emphysema is a disease in which the alveoli walls,which are normally fairly rigid structures, are destroyed. Thedestruction of the alveoli walls is irreversible. Pulmonary emphysemamay be caused by a number of factors, including chronic bronchitis, longterm exposure to inhaled irritants, e.g. air pollution, which damage thecilia, enzyme deficiencies and other pathological conditions. Inpulmonary emphysema, the alveoli of the lungs lose their elasticity, andeventually the walls between adjacent alveoli are destroyed.Accordingly, as more and more alveoli walls are lost, the air exchange(oxygen and carbon dioxide) surface area of the lungs is reduced untilair exchange becomes seriously impaired. The combination of mucushypersecretion and dynamic airway compression are mechanisms of airflowlimitation in chronic obstructive pulmonary disease. Dynamic airwaycompression results from the loss of tethering forces exerted on theairway due to the reduction in lung tissue elasticity. Mucushypersecretion is described above with respect to bronchitis. In otherwords, the breakdown of lung tissue leads to the reduced ability of thelungs to recoil and the loss of radial support of the airways.Consequently, the loss of elastic recoil of the lung tissue contributesto the inability of individuals to exhale completely. The loss of radialsupport of the airways also allows a collapsing phenomenon to occurduring the expiratory phase of breathing. This collapsing phenomenonalso intensifies the inability for individuals to exhale completely. Asthe inability to exhale completely increases, residual volume in thelungs also increases. This then causes the lung to establish in ahyperinflated state where an individual can only take short shallowbreaths. Essentially, air is not effectively expelled and stale airaccumulates in the lungs. Once the stale air accumulates in the lungs,the individual is deprived of oxygen. There is no cure for pulmonaryemphysema, only various treatments, including exercise, drug therapy,such as bronchodilating agents, lung volume reduction surgery and longterm oxygen therapy.

As described above, long term oxygen therapy is widely accepted as thestandard treatment for hypoxia caused by chronic obstructive pulmonarydisease. Typically, oxygen therapy is prescribed using a nasal cannula.There are disadvantages associated with using the nasal cannula. Onedisadvantage associated with utilizing nasal cannula is the significantloss of oxygen between the cannula and the nose, which in turn equatesto more frequent changes in the oxygen source, or higher energyrequirements to generate more oxygen. Another disadvantage associatedwith utilizing nasal cannula is the fact that the cannulas may cause thenasal passages to become dry, cracked and sore.

Transtracheal oxygen therapy has become a viable alternative to longterm oxygen therapy. Transtracheal oxygen therapy delivers oxygendirectly to the lungs using a catheter that is placed through and downthe trachea. Due to the direct nature of the oxygen delivery, a numberof advantages are achieved. These advantages include lower oxygenrequirements due to greater efficiency, increased mobility, greaterexercise capability and improved self image.

The long term oxygen therapy system and method of the present inventionmay be utilized to deliver oxygen directly into the lung tissue in orderto optimize oxygen transfer efficiency in the lungs. In other words,improved efficiency may be achieved if oxygen were to be delivereddirectly into the alveolar tissue in the lungs. In emphysema, alveoliwalls are destroyed, thereby causing a decrease in air exchange surfacearea. As more alveoli walls are destroyed, collateral ventilationresistance is lowered. In other words, pulmonary emphysema causes anincrease in collateral ventilation and to a certain extent, chronicbronchitis also causes an increase in collateral ventilation.Essentially, in an emphysematous lung, the communicating flow of airbetween neighboring air sacs (alveoli), known as collateral ventilation,is much more prevalent as compared to a normal lung. Since air cannot beexpelled from the native airways due to the loss of tissue elasticrecoil and radial support of the airways (dynamic collapse duringexhalation), the increase in collateral ventilation does notsignificantly assist an individual in breathing. The individual developsdsypnea. Accordingly, if it can be determined where collateralventilation is occurring, then the diseased lung tissue may be isolatedand the oxygen delivered to this precise location or locations. Variousmethods may be utilized to determine the diseased tissue locations, forexample, computerized axial tomography or CAT scans, magnetic resonanceimaging or MRI, positron emission tomograph or PET, and/or standardX-ray imaging. Once the diseased tissue is located, pressurized oxygenmay be directly delivered to these diseased areas and more effectivelyand efficiently forced into the lung tissue for air exchange.

FIG. 1 illustrates a first exemplary long term oxygen therapy system100. The system 100 comprises an oxygen source 102, an oxygen carryingconduit 104 and a one-way valve 106. The oxygen source 102 may compriseany suitable device for supplying filtered oxygen under adjustablyregulated pressures and flow rates, including pressurized oxygen tanks,liquid oxygen reservoirs, oxygen concentrators and the associateddevices for controlling pressure and flow rate e.g. regulators. Theoxygen carrying conduit 104 may comprise any suitable biocompatibletubing having a high resistance to damage caused by continuous oxygenexposure. The oxygen carrying conduit 104 comprises tubing having aninside diameter in the range from about 1/16 inch to about ½ inch andmore preferably from about ⅛ inch to about ¼ inch. The one-way valve 106may comprise any suitable, in-line mechanical valve which allows oxygento flow into the lungs 108 through the oxygen carrying conduit 104, butnot from the lungs 108 back into the oxygen source 102. For example, asimple check valve may be utilized. As illustrated in FIG. 1, the oxygencarrying conduit 104 passes through the lung 108 at the site determinedto have the highest degree of collateral ventilation.

The exemplary system 100 described above may be modified in a number ofways, including the use of an in-line filter. In this exemplaryembodiment, both oxygen and air may flow through the system. In otherwords, during inhalation, oxygen is delivered to the lungs through theoxygen carrying conduit 104 and during exhalation, air from the lungsflow through the oxygen carrying conduit 104. The in-line filter wouldtrap mucus and other contaminants, thereby preventing a blockage in theoxygen source 102. In this exemplary embodiment, no valve 106 would beutilized.

In order for the exemplary long term oxygen therapy system 100 tofunction, an air tight seal is preferably maintained where the oxygencarrying conduit 104 passes through the thoracic cavity and lung. Thisseal is maintained in order to sustain the inflation/functionality ofthe lungs. If the seal is breached, air can enter the cavity and causethe lungs to collapse as described above.

A method to create this seal comprises forming adhesions between thevisceral pleura of the lung and the inner wall of the thoracic cavity.This may be achieved using either chemical methods, including irritantssuch as Doxycycline and/or Bleomycin, surgical methods, includingpleurectomy or thoracoscopic talc pleurodesis, or radiotherapy methods,including radioactive gold or external radiation. All of these methodsare known in the relevant art for creating pleurodesis. With a sealcreated at the site for the ventilation bypass, an intervention may besafely performed without the danger of creating a pneumothorax of thelung.

Similarly to ostomy pouches or bags, the oxygen carrying conduit 104 maybe sealed to the skin at the site of the ventilation bypass. In oneexemplary embodiment, illustrated in FIG. 2, the oxygen carrying conduit104 may be sealed to the skin of the thoracic wall utilizing anadhesive. As illustrated, the oxygen carrying conduit 104 comprises aflange 200 having a biocompatible adhesive coating on the skincontacting surface. The biocompatible adhesive would provide a fluidtight seal between the flange 200 and the skin or epidermis of thethoracic wall. In a preferred embodiment, the biocompatible adhesiveprovides a temporary fluid tight seal such that the oxygen carryingconduit 104 may be disconnected from the ventilation bypass site. Thiswould allow for the site to be cleaned and for the long term oxygentherapy system 100 to undergo periodic maintenance.

FIG. 3 illustrates another exemplary embodiment for sealing the oxygencarrying conduit 104 to the skin of the thoracic wall at the site of theventilation bypass. In this exemplary embodiment, a coupling plate 300is sealed to the skin at the site of the ventilation bypass by abiocompatible adhesive coating or any other suitable means. The oxygencarrying conduit 104 is then connected to the coupling plate 300 by anysuitable means, including threaded couplings and locking rings. Theexemplary embodiment also allows for cleaning of the site andmaintenance of the system 100.

FIG. 4 illustrates yet another exemplary embodiment for sealing theoxygen carrying conduit 104 to the skin of the thoracic wall at the siteof the ventilation bypass. In this exemplary embodiment, balloon flanges400 may be utilized to create the seal. The balloon flanges 400 may beattached to the oxygen carrying conduit 104 such that in the deflatedstate, the oxygen carrying conduit 104 and one of the balloon flangespasses through the ventilation bypass anastomosis. The balloon flanges400 are spaced apart a sufficient distance such that the balloon flangesremain on opposite sides of the thoracic wall. When inflated, theballoons expand and form a fluid tight seal by sandwiching the thoracicwall. Once again, this exemplary embodiment allows for easy removal ofthe oxygen carrying conduit 104.

FIG. 5 illustrates yet another exemplary embodiment for sealing theoxygen carrying conduit 104 to the skin of the thoracic wall at the siteof the ventilation bypass. In this exemplary embodiment, a singleballoon flange 500 is utilized in combination with a fixed flange 502.The balloon flange 500 is connected to the oxygen carrying conduit 104in the same manner as described above. In this exemplary embodiment, theballoon flange 500, when inflated, forms the fluid tight seal. The fixedflange 502, which is maintained against the skin of the thoracic wall,provides the structural support against which the balloon exertspressure to form the seal.

If an individual has difficulty exhaling and requires additional oxygen,collateral ventilation bypass may be combined with direct oxygentherapy. FIG. 6 illustrates an exemplary embodiment of a collateralventilation bypass/direct oxygen therapy system 600. The system 600comprises an oxygen source 602, an oxygen carrying conduit 604 havingtwo branches 606 and 608, and a control valve 610. The oxygen source 602and oxygen carrying conduit 604 may comprise components similar to theabove-described exemplary embodiment illustrated in FIG. 1. In thisexemplary embodiment, when the individual inhales, the valve 610 is openand oxygen flows into the lung 612 and into the bronchial tube 614. Inan alternate exemplary embodiment, the branch 608 may be connected tothe trachea 616. Accordingly, during inhalation oxygen flows to thediseased site in the lung or lungs and to other parts of the lungthrough the normal bronchial passages. During exhalation, the valve 610is closed so that no oxygen is delivered and air in the diseased portionof the lung may flow from the lung 612, through one branch 606 and intothe second branch 608 and finally into the bronchial tube 616. In thismanner, stale air is removed and oxygen is directly delivered.

The connection and sealing of the oxygen carrying conduit 604 andbranches 606, 608 to the lung 612 and bronchial tube 614 may be made ina manner similar to that described above.

Although shown and described is what is believed to be the mostpractical and preferred embodiments, it is apparent that departures fromspecific designs and methods described and shown will suggest themselvesto those skilled in the art and may be used without departing from thespirit and scope of the invention. The present invention is notrestricted to the particular constructions described and illustrated,but should be constructed to cohere with all modifications that may fallwithin the scope of the appended claims.

1. A long term oxygen therapy system comprising: an oxygen supply; atleast one conduit having a first end connected to the oxygen supply anda second end being configured to pass directly through the thoracic walland lung of a patient thereby establishing fluid communication betweenthe oxygen supply and the inner volume of the lung, the second end ofthe conduit being positioned in the lung tissue; and a sealing deviceconnected to the at least one conduit, the sealing device configured toprovide a fluid tight seal between the at least one conduit and thethoracic wall.
 2. A long term oxygen therapy system comprising: anoxygen supply; a valve; a first conduit having a first end connected tothe oxygen supply and a second end connected to the valve; at least onesecond conduit having a first end connected to the valve and a secondend having multiple branches, one of the branches being configured topass directly through the thoracic wall and lung of a patient therebyestablishing fluid communication between the oxygen supply, and theinner volume of the lung, the one of the branches having an open endpositioned in the lung tissue, another of the branches configured topass through a bronchus thereby establishing fluid communication betweenthe oxygen supply and the bronchus; and sealing devices connected to themultiple branches, the sealing devices being configured to provide afluid tight seal between the one of the branches passing through thethoracic wall and lung of the patient and the thoracic wall and a fluidtight seal between the other of the branches being configured to passthrough a bronchus of the patient and the thoracic wall of the patient.